Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017060097

FEI Number

3017060097

Entity Name

MLIFE DIAGNOSTICS LLC

City/State/Country

Marshall, TX, US

Establishment Address

511 N. Washington Ave, Marshall, TX 75670, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

mLife Diagnostics LLC (Owner Number: 10075713)

Owner / Operator Contact Address

511 N. Washington Ave, Marshall, TX 75670, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

mLife Verify mLife True+ mLife Classic mLife Verify mLife True+ mLife Classic mLife Classic mLife Verify mLife True+ mLife Verify mLife Classic mLife True+ mLife Verify mLife Classic mLife Verify mLife True mLife Classic mLife True+ mLife Verify

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUY	Test, Barbiturate, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3150	2023-05-02
PUZ	Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3170	2023-05-02
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2023-05-02
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3100	2023-05-02
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3870	2023-05-02
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2020-06-25
PVE	Test, Methadone, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3620	2023-05-02

Official Correspondent

Alan Loudermilk

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

mLife Diagnostics LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

Similar Registrations

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3043534289	MOHE BioTech Production (Mauritius) Ltd.	MOKA, MU
3003917514	BTNX Inc.	Pickering Ontario, CA
3017904598	Guangzhou Decheng Biotechnology Co., Ltd.	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017060097. Last updated year: 2026. Please use registration number 3017060097 when referencing this establishment in official correspondence.